Kiromic BioPharma Reports Positive Six-Week Results for Fourth Deltacel-01 Patient

A recent update from Kiromic BioPharma, Inc., revealed promising preliminary results from their ongoing Deltacel-01 Phase 1 clinical trial. The trial focuses on assessing the safety and efficacy of Deltacel™ (KB-GDT-01), a Gamma Delta T-cell (GDT) therapy, for patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have not responded to standard treatments.

The initial findings from the second cohort's first patient, who is the fourth patient overall in this trial, have shown notable safety and tolerability. Six weeks into the treatment, the patient’s scans indicated stabilization of the disease, with no new metastatic sites and an 8.5% reduction in tumor size. Additionally, the patient experienced significant quality-of-life improvements, such as the discontinuation of prescription pain medications. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

Dr. Afshin Eli Gabayan, the Medical Director and Principal Investigator at BHCC, remarked on the patient’s history, highlighting their previous treatments with chemotherapy, antibody-based immunotherapy, and radiation therapy, none of which had been successful. The six-week follow-up showed stable disease conditions and a remarkable 8.5% reduction in the tumor size compared to pre-treatment results. The patient, who previously required medication for cancer-related pain, no longer needed it post-treatment with Deltacel, demonstrating a significant enhancement in their quality of life.

Pietro Bersani, the CEO of Kiromic BioPharma, expressed optimism about these early results. He emphasized the importance of the observed tumor size reduction and the marked improvement in the patient's quality of life, signaling a positive trajectory for the Deltacel-01 trial. Bersani also mentioned the anticipation of preliminary results from the remaining patients in the second cohort, expected to be reported in June.

The Deltacel-01 trial is an open-label Phase 1 study titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570). Participants in the trial receive two intravenous infusions of Deltacel™ along with four courses of low-dose localized radiation over ten days. The primary goal is to assess the safety of this combination, while secondary objectives include evaluating the objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.

Deltacel™ (KB-GDT-01) is an investigational GDT therapy, leveraging unmodified, donor-derived gamma delta T cells. This therapy aims to harness the natural potency of GDT cells to target solid tumors, with an initial focus on NSCLC, which constitutes 80% to 85% of lung cancer cases. Preclinical studies have previously demonstrated the favorable safety and efficacy of Deltacel™ when combined with low-dose radiation.

The Beverly Hills Cancer Center is a private, academic, community-based facility that offers advanced cancer treatments and clinical trials. It attracts a global patient base by providing access to the latest experimental treatments. The center is staffed by a multidisciplinary team of renowned medical professionals, including oncologists, radiologists, and hematologists, who are supported by an efficient team of clinical research experts.

Kiromic BioPharma, Inc., is a clinical-stage biotherapeutics company specializing in immuno-oncology. Their proprietary DIAMOND® AI 2.0 target discovery engine is instrumental in developing and commercializing cell therapies aimed at solid tumors. Kiromic’s allogeneic cell therapy platform is designed to exploit the natural abilities of Gamma Delta T cells to combat cancer effectively.